FDA Related News

Medical Devices

Guidance on Device Pre-Submission Meetings

FDA releases a final guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

Human Drugs

Guide on Nonclinical Immunotoxic Evaluations

FDA releases a final guidance entitled Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.

Human Drugs

Interstitial Cystitis/Bladder Pain Syndrome Guidance

FDA publishes a draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Drug Development Programs for Treatment.

Federal Register

FDA Withdraws 8 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they informed the agency that the products were no longe...

Biologics

FDA OKs Pfizer Abrysvo RSV Vaccine

FDA approves Pfizers Abrysvo vaccine to prevent respiratory syncytial virus in older adults.

Human Drugs

FDAs Expands Use of Lynparza in Prostate Cancer

FDA approves AstraZeneca and Mercks Lynparza (olaparib) in combination with Janssens Zytiga (abiraterone) and prednisone or prednisolone for treating ...

Human Drugs

Migraine Drug Development Guidance

FDA publishes a draft guidance on the clinical development of drugs to prevent migraine.

Human Drugs

AstraZeneca Ends Brazikumab Development

AstraZeneca says it is ending its brazikumab development program that was being studied for Crohns disease and ulcerative colitis.

Human Drugs

FDA Warning on Unapproved Molluscum Treatments

FDA issues a warning against using unapproved products that claim to treat molluscum.

Balance AI Optimism and Pessimism: Califf

FDA commissioner Robert Califf says he sees value in artificial intelligence and agrees that its important to also look at the risk of harm that can b...